{"data":{"id":"us/21-cfr-170.203","jurisdiction":"us","citation":"21 CFR 170.203","heading":"Definitions.","body":"The definitions and interpretations of terms in § 170.3 apply to such terms when used in this subpart. The following definitions also apply:\nAmendment means any data and information that you submit regarding a filed GRAS notice before we respond to your notice by letter in accordance with § 170.265(b)(1) or cease to evaluate your notice in accordance with § 170.265(b)(3).\nGRAS means generally recognized as safe.\nGRAS notice means a submission that informs us of your view that a substance is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act based on your conclusion that the substance is GRAS under the conditions of its intended use in accordance with § 170.30.\nNotified substance means the substance that is the subject of your GRAS notice.\nNotifier means the person (e.g., an individual, partnership, corporation, association, or other legal entity) who is responsible for the GRAS notice, even if another person (such as an attorney, agent, or qualified expert) prepares or submits the notice or provides an opinion about the basis for a conclusion of GRAS status.\nQualified expert means an individual who is qualified by scientific training and experience to evaluate the safety of substances under the conditions of their intended use in food.\nSupplement means any data and information that you submit regarding a filed GRAS notice after we respond to your notice by letter in accordance with § 170.265(b)(1) or cease to evaluate your notice in accordance with § 170.265(b)(3).\nWe, our, and us refer to the United States Food and Drug Administration (FDA).\nYou and your refer to a notifier.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION","PART 170—FOOD ADDITIVES","Subpart E—Generally Recognized as Safe (GRAS) Notice"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"f71f7485bcfb79f42d0a733adc04b9d59b8ef8cc21a6f7e68e4c01354680616c","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-170.106","next":"us/21-cfr-170.205"},"notice":"GroundRules: Original legal text. Not legal advice."}
